(87 days)
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels. The FilmArray 2.0 is intended for use in combination with assay specific reagent pouches to detect multiple nucleic acid targets contained in clinical specimens.
The FilmArray 2.0 is an automated in vitro diagnostic (IVD) device designed to work with specific FilmArray reagent panels to detect multiple nucleic acid targets contained in clinical specimens. The FilmArray 2.0 instrument interacts with a reagent pouch to both purify nucleic acids and amplify targeted nucleic acid sequences using nested multiplex PCR in a closed system. The resulting PCR products are evaluated using DNA melting analysis. The FilmArray 2.0 software automatically determines the results and provides a test report.
The FilmArray 2.0 permits up to eight instruments to connect to one computer. This configuration reduces the space requirements for the system and offers centralized data management. Accessories for the FilmArray 2.0 include a computer stand and printer, a barcode scanner, an external Ethernet switch that allows several instruments to connect to a single computer, and an optional modular rack system to stack two instruments.
The main functions of the FilmArray 2.0 are as follows:
- Moving liquids within the pouch and delivering rehydrated reagents in a specified . sequence to drive the nucleic acid purification and PCR amplification reactions.
- . Heating and cooling to drive the PCR reactions and DNA melting.
- . Capturing and processing of fluorescence images for analysis by the software.
- . Automated data interpretation and test report generation.
The FilmArray 2.0 device is an automated in vitro diagnostic (IVD) device designed for use with FilmArray panels to detect multiple nucleic acid targets in clinical specimens. The device's performance was evaluated through a series of studies comparing it to the previously cleared FilmArray device (K103175).
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list "acceptance criteria" in a numerical format that can be directly compared to reported device performance. However, the summary of performance data indicates that the device was deemed substantially equivalent to its predicate. The functional equivalence implies that the performance of the FilmArray 2.0 met the expected performance standards demonstrated by the predicate device for various parameters.
| Acceptance Criteria (Inferred from equivalence claim) | Reported Device Performance (FilmArray 2.0 vs. FilmArray, K103175) |
|---|---|
| Equivalent detection in clinical specimens | Performance of all three panels (RP, BCID, GI) was found to be equivalent on FilmArray 2.0 and the previously cleared FilmArray. |
| Equivalent detection of low analyte levels | Performance of all three panels (RP, BCID, GI) was found to be equivalent on FilmArray 2.0 and the previously cleared FilmArray. |
| Equivalent reproducibility | Performance of all three panels (RP, BCID, GI) was found to be equivalent on FilmArray 2.0 and the previously cleared FilmArray. |
2. Sample size used for the test set and the data provenance:
The document mentions that each panel (Respiratory Panel (RP), Blood Culture Identification (BCID) Panel, and Gastrointestinal (GI) Panel) was evaluated in three types of studies:
- Clinical specimen comparison study: Involved testing a set of clinical samples. The exact number of samples is not specified for this summary document, but it compares FilmArray 2.0 to the current FilmArray. The provenance (e.g., country of origin) is not specified, and the study type appears to be retrospective (using existing clinical samples).
- Low analyte study: Compared the performance of the two devices by testing contrived samples spiked around the previously-determined limit of detection (LoD) for each assay on the panel. The number of contrived samples is not specified.
- Reproducibility study: Involved testing a set of well-characterized contrived samples. The number of contrived samples is not specified. This study was conducted at three different testing sites over several days.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not specified in the provided document. The device automatically interprets results, and the ground truth would likely be established through standard microbiology/molecular diagnostic methods against which the device's results are compared, rather than expert human interpretation of the device's raw output.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not specified in the provided document. Given the nature of an automated IVD device, the primary ground truth is usually established by a reference method, not by human adjudication of device outputs.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The FilmArray 2.0 is an automated instrument that provides a direct result without human interpretation of complex images or data that would necessitate a MRMC study. Its output is a test report.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Yes, the studies described are inherently "standalone" in the sense that they evaluate the device's ability to autonomously detect nucleic acid targets and provide a test report. The device’s software automatically determines the results and provides a test report, indicating that a human is not in the loop for the primary result interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the test set would have been established using reference laboratory methods for detecting nucleic acid targets in clinical specimens, and potentially the established Limit of Detection (LoD) for contrived samples. For clinical studies, this would likely involve results from other FDA-cleared diagnostic tests or gold-standard laboratory techniques. The document mentions "well-characterized contrived samples", implying a known composition/presence of analytes.
8. The sample size for the training set:
The document describes performance studies for a medical device that has been developed. It does not provide information on a "training set" in the context of machine learning. The term "training set" is usually associated with the development of AI/ML algorithms. This device relies on established PCR and DNA melting analysis principles, with software interpreting these biophysical reactions. Therefore, there isn't a "training set" in the typical AI sense mentioned here.
9. How the ground truth for the training set was established:
As noted above, there is no mention of a "training set" in the context of AI/ML, as this device uses established molecular diagnostic techniques and software for interpretation. The software's "knowledge" is based on the expected melting curves and PCR amplification patterns of known targets, not on being trained on a dataset with ground truth labels in the same way a deep learning model would be.
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.